FDA accepts aBLA for Avastin biosimilar, MYL 14020.-Mylan

Mylan announced on its quarterly earnings call that the FDA has accepted the company’s aBLA for a biosimilar of Avastin (bevacizumab), which is now under review with a user fee goal date of 27 December 2020. Mylan is the fourth biosimilar developer to report the filing of an aBLA for a bevacizumab biosimilar being MYL 14020. The FDA already approved Amgen’s Mvasi (bevacizumab-awwb) and Pfizer’s Zirabev (bevacizumab-bvzr), both of which launched in the U.S. in 2019. In addition, Samsung Bioepis announced that the FDA accepted its aBLA for a bevacizumab biosimilar this past November 2019. Mylan further disclosed on last week’s call that it recently submitted a “European application” for its bevacizumab biosimilar that is “currently in the validation stage with the authorities. Mylan also mentioned in its quarterly earnings call that it was ‘on track’ for its US submission in the second quarter of 2020 for its insulin aspart biosimilar..